During medical device manufacturing, residual processing agents can pose toxicological risks to patients if not properly removed. To ensure safety, manufacturers must validate cleaning methods and establish acceptable cleaning limits for each potential contaminant. While traditional methods involve individual toxicological assessments, this becomes costly and impractical when dealing with numerous chemicals or incomplete data. Pine Lake Laboratories offers a solution by setting worst-case cleaning limits and using sensitive analytical techniques to identify actual contaminants present, helping manufacturers meet safety standards efficiently.
Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience executing the Biophorum (BPOG) Best Practice Guide for Extractables Testing of Polymeric Single-Use Components Used in Biopharmaceutical Manufacturing. We can perform the extraction as required by the BPOG protocol and aid the client in ensuring the proper experimental design.
Pine Lake Laboratories has a proven track record of developing and validating analytical methods used to insure the quality of antibiotic coated or loaded surgical implants. Our experience spans a wide range of surgical meshes and dental implants. This experience combined with our expertise in performing FDA GMP compliant analytical analysis allows us to develop an analytical testing strategy to meet the unique and specific requirements of any antibiotic coated or loaded surgical implant.
Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience with pharmaceutical container closures, single use system components, and combination devices. Our experienced scientific staff utilizes the following analytical methods for expert identification of extractables observed in a forced extraction study.
Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of combination devices, especially combination pharmaceutical medical devices. Our experience allows us to adapt validation strategies and assist in testing designs to meet the unique challenges of combination devices.
Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of active pharmaceutical ingredients (API) and finished drug products. Our experience allows us to adapt validation strategies and assist in testing designs to meet any unique challenges presented by a new drug in development.
